Biostimulation After Tooth Extraction

Sponsor

Hazal Özer (Other)

Overall Status

Completed

CT.gov ID

NCT06018584

Collaborator

(none)

Enrollment

Arms

17.9

Actual Duration (Months)

Study Details

Study Description

Brief Summary

This study evaluated the effect of low-level laser therapy on postoperative pain and wound healing in children undergoing primary molar extractions 40children, 6-10 years of age, systemically healthy, and had atraumatic extraction indications of bilateral primary molar teeth were included in the study. A randomly selected tooth was extracted under local anesthesia in the first session. Only the clot formation on the socket was observed and photographed in the control group. Other group extractions were performed 2weeks later. The LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and photographed. Non-epithelialized surface measurements were performed with the ImageJ program. Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were performed with SPSS software.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children Wound Heal	Other: Tooth extraction	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effect of Low-Level Laser Therapy in Wound Healing and Post-Operative Pain Management of Primary Molar Teeth Ex-traction: A Randomized Clinical Trial

Actual Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control Group No application was made after the tooth extraction procedure in the control group.	Other: Tooth extraction Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.
Experimental: Low- Level Laser Group (Doctor Smile Wiser) In the Laser group, the diode laser device Doctor Smile Wiser (Wiser, Doctor Smile, Milan, Italy) (Figue 1) with a wavelength of 980 nm and a power of 0.5 W was used for LLLT. During the procedure, the patient, physician, and assistant staff wore protective glasses (Wiser, Doctor Smile, Milan, Italy). With 300 mW of energy, a 400 m tip held 1 cm away from the extraction socket was applied to the extraction socket for 60 seconds from three points determined from the vestibule, lingual/palatal, and occlusal surfaces.	Other: Tooth extraction Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.

Arm

Intervention/Treatment

Sham Comparator: Control Group

No application was made after the tooth extraction procedure in the control group.

Other: Tooth extraction

Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.

Experimental: Low- Level Laser Group (Doctor Smile Wiser)

In the Laser group, the diode laser device Doctor Smile Wiser (Wiser, Doctor Smile, Milan, Italy) (Figue 1) with a wavelength of 980 nm and a power of 0.5 W was used for LLLT. During the procedure, the patient, physician, and assistant staff wore protective glasses (Wiser, Doctor Smile, Milan, Italy). With 300 mW of energy, a 400 m tip held 1 cm away from the extraction socket was applied to the extraction socket for 60 seconds from three points determined from the vestibule, lingual/palatal, and occlusal surfaces.

Other: Tooth extraction

Outcome Measures

Primary Outcome Measures

Wound healing [intervention (tooth extraction) day, 3rd day and 7th day]
For the evaluation of soft tissue healing in extraction sockets, intraoral photographs were taken at an angle of 60° to the occlusal surface on the 3rd and 7th days following the extraction session. Non-epithelialized surface measurements were made by two observing physicians using the ImageJ (NIH, Rockville, USA) program.
Pain score [intervention day (tooth extraction), 3rd day and 7th day]
Pain assessment in both groups was performed with the Wong-Baker Pain Rating Scale (Wong-Baker FACES Pain Rating Scale PRS). Patients were asked to choose a face or number from the scale, and the selected value was the practitioner dentist on the day of the procedure; other days were recorded by the parent. This scale is graded from 0 to 10. 0 indicates no pain, and 10 marks the most severe pain. It is asked to evaluate the pain according to the facial expression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

indication for tooth extraction in bilateral primary molars
did not have any systemic disease
the use of antibiotics and painkillers was stopped at least 12 hours ago

Exclusion Criteria:

require complicated tooth extractions
systemic disease
the use of antibiotics and painkillers in 12 hours

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hazal Özer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hazal Özer, Assist. Prof., Necmettin Erbakan University

ClinicalTrials.gov Identifier:

NCT06018584

Other Study ID Numbers:

2017-07

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Aug 30, 2023